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| Name | Class |
|---|---|
| Sigma Theta Tau International Honor Society of Nursing | OTHER |
| Jonas Philanthropies | UNKNOWN |
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The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation.
This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms [depression, anxiety, pain, sleep, and fatigue]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.
Aim 1: Evaluate early preliminary efficacy of the eMotion intervention
Research hypothesis 1. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have greater improvement in these outcomes over time:
1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life.
Aim 2: Evaluate the cognitive processes as intervention response variables.
Research hypothesis 2. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have:
2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived cardiac threat and general stress 2.3. Improved cognition and motivation
Aim 3. Exploratory. Examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), and symptoms [depression, anxiety, pain, sleep, and fatigue]) among adults enrolled in cardiac rehabilitation after a first major cardiac event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eMotion | Experimental | The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively. Intervention provided in addition to usual cardiac rehabilitation. |
|
| Healthy living active control | Active Comparator | Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation. |
|
| Usual care | No Intervention | Usual cardiac rehabilitation with no additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eMotion | Behavioral | Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate to Vigorous Physical Activity (MVPA) | Minutes spent in MVPA | 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Symptoms | Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS) | Baseline to 12 weeks, 20 weeks, and 52 weeks |
| Change in Anxiety Symptoms | Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly L Wierenga, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health West Hospital | Avon | Indiana | 46123 | United States | ||
| Indiana University Health Bedford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741536 | Derived | Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4. |
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3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
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| Healthy Living Active Control | Behavioral | The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse. |
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| Baseline to 12 weeks, 20 weeks, and 52 weeks |
| Change in Pain Symptoms | Pain will be measured with the Brief Pain Inventory | Baseline to 12 weeks, 20 weeks, and 52 weeks |
| Change in Sleep efficiency | Sleep efficiency will be a calculation of the ratio of the total sleep time to time spent in bed using the ActiGraph wGT3X-BT accelerometer | Baseline to 12 weeks, 20 weeks, and 52 weeks |
| Change in Fatigue Symptoms | Fatigue will be measured using the Fatigue Severity Scale | Baseline to 12 weeks, 20 weeks, and 52 weeks |
| Bedford |
| Indiana |
| 47421 |
| United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Tipton Hospital | Tipton | Indiana | 46072 | United States |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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